TXMD is developing a combination estradiol and progesterone gelatin capsule to treat menopause symptoms. Their product aims to provide a safer and more effective alternative to existing FDA-approved synthetic hormone combinations by using bioidentical estradiol and progesterone. PK studies found their combination tended toward bioequivalence with an estradiol/progesterone combination, and progesterone in their formulation had significantly less variability than Prometrium alone. If approved, their product could capture part of the large domestic and international markets for menopause treatment and help regulate the compounding pharmacy industry.
This document discusses drugs and medicine in pharmacology. It defines drugs and medicines, and explains their differences. Drugs are chemical substances intended to treat or prevent disease, while medicines have a definite form and dose. The document also outlines various sources of drugs, including plants, animals, minerals, microbes, synthesis and biotechnology. Finally, it provides examples of drug nomenclature and classifications of medicines based on their active ingredients and excipients.
The Transfer Of Drugs And Other Chemicals Into Human Breast MilkBiblioteca Virtual
The document provides 4 tables that list drugs and other chemicals that are transferred into human breast milk. Table 1 lists drugs that are contraindicated during breastfeeding. Table 2 lists drugs that require temporary cessation of breastfeeding. Table 3 lists maternal medications that are usually compatible with breastfeeding. Table 4 lists miscellaneous agents and their possible effects on infants or lactation. The tables are meant to assist physicians in counseling patients about breastfeeding while taking various medications.
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Betamethasone 0.5mg Tablet Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Betamethasone Dosage & Rx Info | Betamethasone Uses, Side Effects – Antifungal/ Antibacterial, Betamethasone 1mg/ml Oral Solution: Indications, Side Effects, Warnings, Betamethasone - Drug Information - Taj Pharma, Betamethasone dose Taj pharmaceuticals Betamethasone interactions, Taj Pharmaceutical Betamethasone contraindications, Betamethasone price, Betamethasone , Taj Pharma Betamethasone 0.5mg Tablet - Taj Pharma . Stay connected to all updated on Betamethasone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.
This investor presentation provides an overview of TherapeuticsMD and its hormone therapy drug candidates.
1) TherapeuticsMD has two late-stage hormone therapy products targeting a multi-billion dollar market, consisting of a bioidentical combination of estradiol and progesterone, and a lower-dose bioidentical progesterone.
2) The company has converted approved drugs into new liquid forms achieving uniformity and stability, enabling new combinations, routes, and dosages through a novel drug design approach.
3) TherapeuticsMD is building an extensive patent estate around its solubilized drug form platform technology for hormone therapy indications.
The document discusses hormone therapies and their application protocols used in treatment. It provides details on various hormones including estrogens, progestogens, and their classification. It describes different hormone therapy regimens including sequential and continuous combined preparations. Application methods like oral, transdermal, and local administration are outlined. Guidelines for irregular bleeding management and contraindications for hormone therapy are also summarized.
This document discusses drugs and medicine in pharmacology. It defines drugs and medicines, and explains their differences. Drugs are chemical substances intended to treat or prevent disease, while medicines have a definite form and dose. The document also outlines various sources of drugs, including plants, animals, minerals, microbes, synthesis and biotechnology. Finally, it provides examples of drug nomenclature and classifications of medicines based on their active ingredients and excipients.
The Transfer Of Drugs And Other Chemicals Into Human Breast MilkBiblioteca Virtual
The document provides 4 tables that list drugs and other chemicals that are transferred into human breast milk. Table 1 lists drugs that are contraindicated during breastfeeding. Table 2 lists drugs that require temporary cessation of breastfeeding. Table 3 lists maternal medications that are usually compatible with breastfeeding. Table 4 lists miscellaneous agents and their possible effects on infants or lactation. The tables are meant to assist physicians in counseling patients about breastfeeding while taking various medications.
Betamethasone 0.5mg tablets pil, taj pharmaceuticals.Taj Pharma
Betamethasone 0.5mg Tablet Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Betamethasone Dosage & Rx Info | Betamethasone Uses, Side Effects – Antifungal/ Antibacterial, Betamethasone 1mg/ml Oral Solution: Indications, Side Effects, Warnings, Betamethasone - Drug Information - Taj Pharma, Betamethasone dose Taj pharmaceuticals Betamethasone interactions, Taj Pharmaceutical Betamethasone contraindications, Betamethasone price, Betamethasone , Taj Pharma Betamethasone 0.5mg Tablet - Taj Pharma . Stay connected to all updated on Betamethasone Taj Pharmaceuticals Taj pharmaceuticals Hyderabad. Patient Information Leaflets, PIL.
This investor presentation provides an overview of TherapeuticsMD and its hormone therapy drug candidates.
1) TherapeuticsMD has two late-stage hormone therapy products targeting a multi-billion dollar market, consisting of a bioidentical combination of estradiol and progesterone, and a lower-dose bioidentical progesterone.
2) The company has converted approved drugs into new liquid forms achieving uniformity and stability, enabling new combinations, routes, and dosages through a novel drug design approach.
3) TherapeuticsMD is building an extensive patent estate around its solubilized drug form platform technology for hormone therapy indications.
The document discusses hormone therapies and their application protocols used in treatment. It provides details on various hormones including estrogens, progestogens, and their classification. It describes different hormone therapy regimens including sequential and continuous combined preparations. Application methods like oral, transdermal, and local administration are outlined. Guidelines for irregular bleeding management and contraindications for hormone therapy are also summarized.
The document summarizes the history and development of oral contraception. It discusses key figures like Ludwig Haberlandt, Russell Marker, Carl Djerassi, and Gregory Pincus who contributed to early research. It also describes the components of combination oral contraceptives including estrogens like ethinyl estradiol and progestins like norethindrone. The mechanisms of action and efficacy of combination oral contraceptives are explained.
The document discusses the importance of pharmacovigilance for biotherapeutic medicines. It notes that biotherapeutics are more complex and difficult to characterize than traditional small molecule drugs due to their large size and biological production processes. This underscores the importance of specific traceability for biotherapeutics in pharmacovigilance activities. The document recommends that the WHO work to develop global naming recommendations for biotherapeutics to facilitate accurate tracking and tracing of products and linkage of adverse events to the appropriate product. It also discusses new EU legislation requiring identification of biotherapeutics by brand name and batch number in adverse event reporting.
The document provides an overview of a specialty pharmaceutical company and its product pipeline. It summarizes 6 abbreviated new drug applications (ANDAs) under FDA review for generic versions of branded drugs representing $6.6 billion in sales. It also describes a proprietary abuse-resistant drug delivery platform. Examples of potential US market size and revenue for the generic products are estimated based on assumptions around market share and pricing.
The document provides an overview of a specialty pharmaceutical company and its product pipeline. It summarizes 6 ANDA applications for generic versions of branded extended release drugs that are under review by the FDA. The applications represent $6.6 billion in branded and generic sales. It also describes the company's controlled release drug delivery platform and strategic partnerships. Examples of potential US market sizes for some products are estimated based on assumptions about market share and pricing to illustrate the variability in generics economics.
This document provides an overview of biosimilars. It discusses that biosimilars are similar versions of biologic drugs that are set to lose patent protection. This presents both opportunities to make cheaper biologics to increase access, as well as regulatory challenges to demonstrate similarity. The global biosimilars market is growing, driven by both developed and emerging markets. India is emerging as a key player, with companies developing biosimilars for both domestic and export markets. However, hurdles remain around establishing clear regulatory pathways and demonstrating similarity to reference biologics.
Usually drug interactions occur when Buy Naturogest 200 mg is taken with another drug or with food. Before you take a medication for a particular ailment, you should inform the health expert about intake of any other medications including non-prescription medications, over-the-counter medicines that may increase the effect of Progesterone, and dietary supplements like vitamins, minerals and herbal, so that the doctor can warn you of any possible drug interactions.
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The document discusses proteins and peptides as pharmaceutical drugs. It provides an overview of the protein therapeutics market, major brands that generate over $1 million in revenue, production costs, challenges in the field, and regulatory considerations for approval of protein and peptide drugs.
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The document discusses proteins and peptides as pharmaceutical drugs. It provides an overview of the protein therapeutics market, major brands that generate over $1 million in revenue, production costs, challenges of developing protein and peptide drugs, and regulatory considerations for approval of drugs derived from recombinant DNA technology.
A sweet manual to hormone replacement treatment products and services. Call now to speak with one of our clinical specialists now to get you started on the path to youthfullness.
The document discusses generic drugs and biosimilars. It provides biographical information about the speaker and outlines key questions about generics that will be addressed. Generic drugs are defined as comparable but not identical to brand name drugs in dosage, strength, quality and performance. Biosimilars are similar to biologic drugs but require more extensive testing than generics due to their complex nature. The market for generic drugs is large and growing, particularly in emerging markets, as major drugs lose patent protection.
The document provides an overview of general pharmacology concepts including definitions of pharmacology and drugs. It discusses the objectives of studying pharmacology and defines key terms like receptors, pharmacokinetics, pharmacodynamics, drug sources, nomenclature, dosage forms, and routes of drug administration with a focus on oral, parenteral, and other enteral routes. The document aims to introduce students to the basic concepts and principles of pharmacology.
One mans supergeneric is anothers life cycle managementMalcolm Ross
This document discusses the potential for generic pharmaceutical companies to develop "supergeneric" or value-added generic drug products. It provides examples of how simple reformulations or new delivery methods for off-patent drugs could create differentiated products with improved efficacy or compliance compared to existing generics. Developing combination products or modified release formulations are presented as opportunities requiring relatively little investment that leverage existing technical skills at generic companies.
Pegylation & biosimilars global scenarioMalay Singh
The document defines drugs and devices under the Drugs and Cosmetics Act of 1940 in India. It states that drugs include all medicines, substances and components for internal or external use, while devices are meant to treat, mitigate or prevent disease. Biologics and biosimilars are also included. The document then provides definitions and explanations of biotechnology, biopharmaceuticals, proteins drugs, pegylation, biologics vs biosimilars, and the FDA approach to biosimilars.
This document outlines Pfizer's plans to acquire Wyeth to create the world's premier biopharmaceutical company. The acquisition will diversify Pfizer's portfolio and strengthen its leadership in key therapeutic areas and geographies. Pfizer expects the deal to advance its strategic priorities and deliver $2 billion in cost savings by 2011 on top of $4 billion in synergies from the transaction. The all-cash-and-stock deal is valued at $68 billion and will be funded through cash, debt, and Pfizer stock.
The document discusses Pfizer's plans to create the world's premier biopharmaceutical company through acquiring Wyeth. The acquisition will strengthen Pfizer's leadership in key areas like biologics and vaccines, expand its portfolio of growth drivers, and enhance its scientific and manufacturing capabilities. It analyzes how the acquisition advances Pfizer's strategic objectives such as becoming a leader in biologics, entering the vaccines market, and expanding in emerging markets. Charts show how the combined company will have a more diversified portfolio of therapies and platforms.
This document provides information for pharmacists and pharmacy technicians on over-the-counter medications that are commonly used and recommended for pets. It discusses common conditions that pet owners seek to treat with OTC drugs and identifies medications that are unsafe for cats, dogs, and certain breeds. It also covers counseling pet owners on appropriate dosing and administration of OTC drugs for their pets. The document aims to help pharmacists and technicians safely advise pet owners and identify potential issues with ingredients, such as propylene glycol, alcohol, and xylitol, in some OTC products.
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The document discusses regulatory affairs and licensing of medicines. It provides information on what a medicine license includes, such as approved uses, dosages, storage instructions, and safety warnings. It also discusses unlicensed medicines that are used off-label without undergoing full clinical trials. Different types of drug sales licenses are described, including those for retail sales, wholesale distribution, and manufacturing. Drug recalls are also summarized, with examples provided of recent recalls due to issues like mislabeling, particulate contamination, or undeclared drug ingredients.
FloLyf is a multi-level marketing company that promotes health and wellness products through a network of leaders. It operates according to the values of passion, excellence, agility, respect, and leadership. The company aims to lead in marketing innovative products through an accessible sales and marketing system for network builders. It offers various membership packages for starting a FloLyf business, as well as opportunities to earn retail profits, referral bonuses, match bonuses, and unilevel bonuses through its compensation plan.
ProAlgaZyme® (PAZ) is an algae infusion made from algae discovered in a secret freshwater ecosystem. It is grown in controlled environments and filtered to make the infusion. PAZ supports immune health, maintains cardiovascular health, promotes normal inflammation response, and helps maintain healthy weight and blood sugar levels. Independent clinical studies show PAZ is safe and well-tolerated when consumed up to a bottle per day for 12 weeks.
GlaxoSmithKline (GSK) is a large research-based pharmaceutical company with a mission to improve human life. It has major research centers globally and produces many leading medicines to treat diseases like HIV, malaria, tuberculosis, asthma, and cancers. Panadol Extra is one of GSK's well-known pain relief products containing paracetamol and ibuprofen. It faces competition from other paracetamol-containing drugs but maintains its market position through extensive research and development, global market reach, charitable activities, and its trusted brand recognition as a leader in pain relief.
The document summarizes the history and development of oral contraception. It discusses key figures like Ludwig Haberlandt, Russell Marker, Carl Djerassi, and Gregory Pincus who contributed to early research. It also describes the components of combination oral contraceptives including estrogens like ethinyl estradiol and progestins like norethindrone. The mechanisms of action and efficacy of combination oral contraceptives are explained.
The document discusses the importance of pharmacovigilance for biotherapeutic medicines. It notes that biotherapeutics are more complex and difficult to characterize than traditional small molecule drugs due to their large size and biological production processes. This underscores the importance of specific traceability for biotherapeutics in pharmacovigilance activities. The document recommends that the WHO work to develop global naming recommendations for biotherapeutics to facilitate accurate tracking and tracing of products and linkage of adverse events to the appropriate product. It also discusses new EU legislation requiring identification of biotherapeutics by brand name and batch number in adverse event reporting.
The document provides an overview of a specialty pharmaceutical company and its product pipeline. It summarizes 6 abbreviated new drug applications (ANDAs) under FDA review for generic versions of branded drugs representing $6.6 billion in sales. It also describes a proprietary abuse-resistant drug delivery platform. Examples of potential US market size and revenue for the generic products are estimated based on assumptions around market share and pricing.
The document provides an overview of a specialty pharmaceutical company and its product pipeline. It summarizes 6 ANDA applications for generic versions of branded extended release drugs that are under review by the FDA. The applications represent $6.6 billion in branded and generic sales. It also describes the company's controlled release drug delivery platform and strategic partnerships. Examples of potential US market sizes for some products are estimated based on assumptions about market share and pricing to illustrate the variability in generics economics.
This document provides an overview of biosimilars. It discusses that biosimilars are similar versions of biologic drugs that are set to lose patent protection. This presents both opportunities to make cheaper biologics to increase access, as well as regulatory challenges to demonstrate similarity. The global biosimilars market is growing, driven by both developed and emerging markets. India is emerging as a key player, with companies developing biosimilars for both domestic and export markets. However, hurdles remain around establishing clear regulatory pathways and demonstrating similarity to reference biologics.
Usually drug interactions occur when Buy Naturogest 200 mg is taken with another drug or with food. Before you take a medication for a particular ailment, you should inform the health expert about intake of any other medications including non-prescription medications, over-the-counter medicines that may increase the effect of Progesterone, and dietary supplements like vitamins, minerals and herbal, so that the doctor can warn you of any possible drug interactions.
Marketing of Proteins and Peptide Pharmaceuticalsguest6c594976
The document discusses proteins and peptides as pharmaceutical drugs. It provides an overview of the protein therapeutics market, major brands that generate over $1 million in revenue, production costs, challenges in the field, and regulatory considerations for approval of protein and peptide drugs.
Marketing of Protein and Peptide Pharmaceuticalssasannasoohi
The document discusses proteins and peptides as pharmaceutical drugs. It provides an overview of the protein therapeutics market, major brands that generate over $1 million in revenue, production costs, challenges of developing protein and peptide drugs, and regulatory considerations for approval of drugs derived from recombinant DNA technology.
A sweet manual to hormone replacement treatment products and services. Call now to speak with one of our clinical specialists now to get you started on the path to youthfullness.
The document discusses generic drugs and biosimilars. It provides biographical information about the speaker and outlines key questions about generics that will be addressed. Generic drugs are defined as comparable but not identical to brand name drugs in dosage, strength, quality and performance. Biosimilars are similar to biologic drugs but require more extensive testing than generics due to their complex nature. The market for generic drugs is large and growing, particularly in emerging markets, as major drugs lose patent protection.
The document provides an overview of general pharmacology concepts including definitions of pharmacology and drugs. It discusses the objectives of studying pharmacology and defines key terms like receptors, pharmacokinetics, pharmacodynamics, drug sources, nomenclature, dosage forms, and routes of drug administration with a focus on oral, parenteral, and other enteral routes. The document aims to introduce students to the basic concepts and principles of pharmacology.
One mans supergeneric is anothers life cycle managementMalcolm Ross
This document discusses the potential for generic pharmaceutical companies to develop "supergeneric" or value-added generic drug products. It provides examples of how simple reformulations or new delivery methods for off-patent drugs could create differentiated products with improved efficacy or compliance compared to existing generics. Developing combination products or modified release formulations are presented as opportunities requiring relatively little investment that leverage existing technical skills at generic companies.
Pegylation & biosimilars global scenarioMalay Singh
The document defines drugs and devices under the Drugs and Cosmetics Act of 1940 in India. It states that drugs include all medicines, substances and components for internal or external use, while devices are meant to treat, mitigate or prevent disease. Biologics and biosimilars are also included. The document then provides definitions and explanations of biotechnology, biopharmaceuticals, proteins drugs, pegylation, biologics vs biosimilars, and the FDA approach to biosimilars.
This document outlines Pfizer's plans to acquire Wyeth to create the world's premier biopharmaceutical company. The acquisition will diversify Pfizer's portfolio and strengthen its leadership in key therapeutic areas and geographies. Pfizer expects the deal to advance its strategic priorities and deliver $2 billion in cost savings by 2011 on top of $4 billion in synergies from the transaction. The all-cash-and-stock deal is valued at $68 billion and will be funded through cash, debt, and Pfizer stock.
The document discusses Pfizer's plans to create the world's premier biopharmaceutical company through acquiring Wyeth. The acquisition will strengthen Pfizer's leadership in key areas like biologics and vaccines, expand its portfolio of growth drivers, and enhance its scientific and manufacturing capabilities. It analyzes how the acquisition advances Pfizer's strategic objectives such as becoming a leader in biologics, entering the vaccines market, and expanding in emerging markets. Charts show how the combined company will have a more diversified portfolio of therapies and platforms.
This document provides information for pharmacists and pharmacy technicians on over-the-counter medications that are commonly used and recommended for pets. It discusses common conditions that pet owners seek to treat with OTC drugs and identifies medications that are unsafe for cats, dogs, and certain breeds. It also covers counseling pet owners on appropriate dosing and administration of OTC drugs for their pets. The document aims to help pharmacists and technicians safely advise pet owners and identify potential issues with ingredients, such as propylene glycol, alcohol, and xylitol, in some OTC products.
Licencing & drug recall of 2014 & 2015 Tahira Sultana
The document discusses regulatory affairs and licensing of medicines. It provides information on what a medicine license includes, such as approved uses, dosages, storage instructions, and safety warnings. It also discusses unlicensed medicines that are used off-label without undergoing full clinical trials. Different types of drug sales licenses are described, including those for retail sales, wholesale distribution, and manufacturing. Drug recalls are also summarized, with examples provided of recent recalls due to issues like mislabeling, particulate contamination, or undeclared drug ingredients.
FloLyf is a multi-level marketing company that promotes health and wellness products through a network of leaders. It operates according to the values of passion, excellence, agility, respect, and leadership. The company aims to lead in marketing innovative products through an accessible sales and marketing system for network builders. It offers various membership packages for starting a FloLyf business, as well as opportunities to earn retail profits, referral bonuses, match bonuses, and unilevel bonuses through its compensation plan.
ProAlgaZyme® (PAZ) is an algae infusion made from algae discovered in a secret freshwater ecosystem. It is grown in controlled environments and filtered to make the infusion. PAZ supports immune health, maintains cardiovascular health, promotes normal inflammation response, and helps maintain healthy weight and blood sugar levels. Independent clinical studies show PAZ is safe and well-tolerated when consumed up to a bottle per day for 12 weeks.
GlaxoSmithKline (GSK) is a large research-based pharmaceutical company with a mission to improve human life. It has major research centers globally and produces many leading medicines to treat diseases like HIV, malaria, tuberculosis, asthma, and cancers. Panadol Extra is one of GSK's well-known pain relief products containing paracetamol and ibuprofen. It faces competition from other paracetamol-containing drugs but maintains its market position through extensive research and development, global market reach, charitable activities, and its trusted brand recognition as a leader in pain relief.
2. Forward-Looking Statements
This presentation includes forward-looking statements covered by the safe harbor provision of the
Private Securities Litigation Reform Act of 1995, including predictions, estimates or other information
that might be considered forward-looking. While these forward-looking statements represent our
current judgment on what the future holds, they are subject to risks and uncertainties, many of which
are outside our control, that could cause actual results to differ materially from the results discussed in
the forward-looking statements.
You are cautioned not to place undue reliance on these forward-looking statements, which reflect our
opinions only as of the date of this presentation. Please keep in mind that we are not obligating
ourselves to revise or publicly release the results of any revision to these forward-looking statements
in light of new information, future events, or otherwise.
Throughout this presentation, we will attempt to present some important factors relating to our
business that may affect our predictions. You should also review our most recent Form 10-K and Form
10-Q for a more complete discussion of these factors and other risks, particularly under the heading
“Risk Factors.” A PDF copy of our press releases and financial tables can be viewed and downloaded
on the TherapeuticsMD website: www.therapeuticsmd.com/InvestorRelations.aspx.
Confidential 1
3. Management Team
• Robert Finizio, Founder and CEO. 17 years of clinical and vendor healthcare
experience at Omnicell Technologies and Endoscopy Specialist Incorporated. Co-
Founded CareFusion in 2001, which was acquired by Cardinal Health in 2006.
• John Milligan, President. 20 years of healthcare experience at Omnicell, serving
software and HBOC, the last two bought by McKesson. Co-Founded CareFusion
alongside Robert Finizio.
• Dan Cartwright, Chief Financial Officer. 20 years of financial management
experience, including M&A and as a CFO of both private and public companies,
including American Wireless Systems, Telegeography, and WEB Corp.
• Julia Amadio, Chief Product Officer. 25-year background in general
management, leading pharmaceutical marketing and product development initiatives
focused on women’s health, including J&J’s McNeil Pharmaceutical, Wyeth (Prempro,
Premphase, Alesse, and Crinone), Rhone-Poulenc (CombiPatch / Estalis), Aventis
(Actonel and Lantus), and Daiichi.
• Dr. Brian Bernick, Founder and Chief Medical Director. Obstetrician /
gynecologist with 19 years of clinical medical experience. Current board member of
VitalMD, LLC, the nation’s largest physician-owned and managed medical group with
gross revenue exceeding $165 million annually.
• Jason Spitz, Vice President of Marketing. 24 years of sales, marketing,
advertising, and general management experience, including a 15-year career at
Schering-Plough and subsequent commercial leadership roles at Aesgen, Inc., MGI
Pharma, and Beacon Healthcare Communications.
Confidential 2
4. Experienced Drug Development Team
• Julia Amadio and James Pickar, M.D., F.A.C.O.G.
‒ Developed and launched some of the most successful HRT and birth control products,
including Prempro, Premphase, Combi-Patch, Alesse, and Crinone
• Lisa Rarick, M.D. and Daniel Shames M.D.
‒ Former Division Directors of Reproductive and Urologic Products for FDA Center for
Drug Evaluation and Research (“CDER”)
• Fred Sancilio
‒ President of AAI and the innovator of estradiol
• Steve Fontana
‒ Author of the original estradiol patents
• Bill Mulholland
‒ Lead patent attorney; previously, IP counsel at Pfizer
• Carol Houts
‒ President of Clinartis (CRO) with significant experience in women’s health (specifically
HRT)
Confidential 3
5. Board of Directors and Investors
• Honorable Tommy G. Thompson (Chairman)
‒ Former 4-term Governor of Wisconsin and former U.S. Secretary of Health
and Human Services
• Mario Family Partnership (Investor)
‒ Former CEO of GlaxoSmithKline, Alza, and Reliant Pharmaceuticals
• Sam Greco
‒ Current CEO of Careview Communications and former Senior Vice President
of Colombia / HCA Hospital Systems
• Steve Williamson
‒ Senior Vice President and General Manager of the GYN Surgical Products
Division of Hologic Inc.
• Seavest Venture Capital
‒ Venture capital arm of Seavest Inc.; 30-year history of investing in healthcare
• Pernix Therapeutics Holdings
‒ Specialty pharmaceutical company engaged in the development, marketing,
and sale of branded and generic pharmaceutical products primarily for the
pediatric market
Confidential 4
7. Menopause- the Patient
Symptoms
• Menstrual periods occur less often,
eventually stop
• Heart pounding or racing
• Hot flashes, worse in first 1 - 2 years
• Night sweats
• Skin flushing
• Sleeping problems (insomnia)
Treatment
HORMONE THERAPY
• Helps severe hot flashes, night sweats,
mood issues, or vaginal dryness
• Estrogen and, sometimes, progesterone
Confidential 6
9. HRT Overview
• Menopause and its symptoms are due to the female ovary ceasing
production of two hormones 17β Estradiol and Progesterone.
• TXMD has the first and only combination product to replace the
declining hormone levels with the exact hormones of 17β Estradiol
and Progesterone that the body has stopped producing.
• First and only solution to use Bio-Identical hormones to treat the
symptoms of menopause due to the reduction of those hormones.
Estradiol Progesterone
Confidential 8
10. TXMD Product Goals
1. Introduce the first and only FDA approved natural Bio-Identical
combination (Estradiol+Progesterone) Hormone Replacement product
suite to compete with Synthetic Combinations
2. Provide an FDA approved alternative to Compound Pharmacy sales of
Progesterone and Estradiol in combination that were between $100-
$350 million in 2011
3. Introduce a safer (when compared to synthetic combinations¹), more
effective product line
4. Leverage this platform and profile into other therapeutic solutions in
Women’s Health
1 The Writing Group for PEPI, JAMA, Jan 1995;273:3;199-208.
Confidential 9
11. 2011 Progestin Sales
When Sold Alone - Natural Progesterone Dominates the Market
2011 Sales Product / Generic
Product Progestin ($mm) Company Available
Provera /
Medroxyprogesterone Acetate Synthetic $ 25.5
Aygestin /
Norethindrone Acetate Synthetic 44.8
Prometrium /
Micronized Progesterone Natural 247.2
Total Oral Progestin Sales $ 317.5
Sources: Company filings, Bloomberg, and IMS.
Confidential 10
12. FDA Approved Combination with Natural Progesterone is a Void
in the Market
2011 Sales
Product Progestin ($mm) Product(s) Company
Synthetic Activella /
Estradiol + Progestin $ 177.7
Progestin Angeliq
Synthetic Premphase /
Premarin + Progestin 290.2
Progesitn Prempro
Pharmacy Compounding:
Natural 96-350
Estradiol + Progesterone (1)
Total Oral Combination Sales $ 564.0
Sources: Company filings, Bloomberg, and IMS.
Notes: All FDA-approved combination products use a synthetic progestin.
1) Compounding sales of HRT products are not FDA approved.
Confidential 11
13. Progesterone vs. Synthetic Progestin
Side Effect Progesterone Synthetic Progestins (eg“MPA, NETA”)
Micronized progesterone and
estrogen results in
Lipid profile Limited effects on lipid profile
significantly higher HDL-C
than MPA
Cardiovascular More favorable VTE profile Less favorable VTE profile
Augments pancreatic Deterioration of glucose tolerance or
Glucose / insulin
response to insulin hyperinsulemia or both
Micronized progesterone and
Sleep / mood estrogen significantly No benefit on sleep properties
improve sleep efficiency
Breast cancer More favorable profile Less favorable profile
Improvement in symptoms and overall satisfaction with
Quality of Life micronized progesterone HRT therapy when compared to MPA
regimen
Confidential 12
14. Bioavailability Study
Prometrium (progesterone) plus Estrace (estradiol) vs. TX-12-
001 new combination gelatin tablet of Progesterone & Estradiol
• Conducted PK studies in FDA audited and approved site in India
• TXMD Combination Gelatin Tablet vs. Estrace and Prometrium
• Based on Cmax and AUC, both estradiol and progesterone tended toward
bioequivalence.
• Progesterone, delivered in our formulation, had a significant reduction of
variance between subjects, consistent with expectations.
Confidential 13
15. TXMD Progesterone vs. Prometrium
(combination)
Semilog Plots of Mean Plasma Concentrations over Time for Progesterone
(Corrected) Study 352
N=24
100.000
Therapeutic Threshold = 30ng/ml
10.000 Endometrial Protection
1.000
Treatment=R
Treatment=T
0.100
0.010
0.001
Sources: Bloomberg and5IMS.
0 10 15 20 25 30 35 40 45 50
Time (hr)
Confidential 14
16. TXMD Estradiol vs. Estrace
(combination)
Semilog plots of Mean Plasma Concentrations over time for Total Estrone Study
N=24
100.00
Therapeutic Threshold = 10pg/ml
10.00
Vasomotor Symptom Relief
1.00
Treatment=R
Treatment=T
0.10
0.01
0 5 10 15 20 25 30 35 40 45 50
Sources: Bloomberg and IMS.
Time (hr)
Confidential 15
17. Benefits of Our Product
TXMD’s novel combination of 17β estradiol and progesterone may provide a
safer and more effective alternative for hormone therapy.¹²³
1. A safer product is seen as a result of a better lipid and CV profile for
progesterone versus synthetic progestins ¹
2. A more effective product is seen as a result of less variability and higher
bioavailability of the progesterone versus RLD when used in this
formulation.³
House panel grills FDA about
compounding pharmacies
1 The Writing Group for PEPI, JAMA, Jan 1995;273:3;199-208
2 Notelovitz et al,Obstet & Gynecol. 2000;95:726-31. and Hitchcock, CL et al. Menopause 2012;19:8;886-93.
3 Study 352 322 PK results
Confidential 16
18. Favorable Risk Profile
• Progesterone and Estradiol are VERY clearly understood by the FDA
‒ Phase 3 endpoints are monographed on FDA website
‒ Therapeutic blood levels with new forms have been achieved
‒ Phase 3 studies offer Lower Risk, Capital and Time when compared with
typical NCE or new drugs that address large markets
‒ FDA approved combination (E+P) product would help FDA contain compounding
pharmacies
Confidential 17
19. Combination Phase 3 Costs and Timeline
2012F 2013P 2014P 2015P
Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15
Filed File NDA
IND NDA Approval
Pilot PK
NDA and PDUFA
Studies
Estradiol
+
Progesterone Pivotal PK
Phase 3 Vasomotor and Endometrial Protection Study
Studies
Study – Combination Cost Location
Pivotal PK $3,545,816 US
Phase 3 $16,508,075 30% Russia / 70% US
Sources: Bloomberg and IMS.
Total $20,053,891
Confidential 18
20. New Drug Cost vs. Opportunity
• $600 Million Domestic Combination Market
• $1+ Billion International Market
• Safer, more effective than current FDA approved solutions
• One of the most comonly Pharmacy compounded products with annual
sales of $100-350 million in 2011 in the US
• Supports Bio-Identical Trend
• Supports all Post WHI Trends
• Phase 3 risk is marginal compared to New Chemical Entities risk for large
market drugs
Sources: Bloomberg and IMS.
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22. When Sold Alone - Natural Progesterone Dominates
the Market
2011 Sales Product / Generic
Product Progestin ($mm) Company Available
Provera /
Medroxyprogesterone Acetate Synthetic $ 25.5
Aygestin /
Norethindrone Acetate Synthetic 44.8
Prometrium /
Micronized Progesterone Natural 247.2
Total Oral Progestin Sales $ 317.5
Sources: Company filings, Bloomberg, and IMS.
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23. PK Study Summaries
• Conducted PK studies in FDA audited and approved site in India
• Progesterone
‒ 24 males
‒ Fed and fasted
‒ Single dose crossover, 18 blood draws pre and post dose
• Estradiol
‒ 24 post-menopausal women
‒ Fed and Fasted
‒ Single dose crossover, 18 blood draws pre and post dose
Confidential 22
25. Progesterone PK Fed Study Stats
Dependent RLD Test Ratio (%)
Geo LSM Geo LSM
Cmax 12.466 20.834 167.13
AUC0-t 29.937 42.681 142.57
AUC0-I 36.992 59.046 159.62
Tmax 3.25 3.26 100.31
Overall results show a 2:1 ratio of the test versus the
RLD for key parameters, indicating potential lowering
of the dose by one half.
Progesterone Fasted Study showed negligible results for both Reference and Test, due to the
high food effect with this hormone.
Confidential 24